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Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection

ConditionThumb Osteoarthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGoed Medisch Centrum

About this trial

The goal of this clinical trial is to evaluate whether platelet-rich plasma (PRP) injections improve pain and function in adults with thumb base osteoarthritis (CMC-I OA).

The main questions it aims to answer are:

Does a PRP injection reduce pain compared to a placebo (saline) injection? Does PRP improve hand function, strength, and thumb mobility? What adverse events occur following PRP treatment?

Researchers will compare PRP injections to a placebo injection (saline solution) to determine whether PRP is an effective treatment for CMC-I osteoarthritis.

Participants will:

Receive a single ultrasound-guided injection of PRP or placebo (saline) in the CMC-I joint.

Attend follow-up visits at 3, 6, 9, and 12 months for clinical assessments. Complete questionnaires on pain (VAS) and hand function (MHQ-DLV) at multiple time points.

Undergo physical examinations (grip strength, pinch strength, thumb motion). Undergo ultrasound evaluations to assess joint characteristics.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older

Patients with an Eaton-littler score of I, II or III

Patients with uni- or bilateral CMC-I osteoarthritis

Non-responders to conservative therapy i.e., hand therapy and immobilisation after 3 months

Disqualifiers

Aged below 18

Patients with an Eaton-littler score of IV (STT arthrosis)

Surgical interventions of the CMC-I joint

A known articular systemic disease (e.g. rheumatoid arthritis) or additional hand osteoarthritis/ tenosynovitis or metabolic disease like diabetes mellitus

Trial design

Design model

Parallel

Treatments tested in this trial

  • Platelet-Rich Plasma (PRP) Injections

    Biological/Vaccine

    Autologous platelet-rich plasma (PRP) is prepared from 90 mL of the participant's venous blood using a standardized two-step centrifugation protocol (ACP® Max system, Arthrex Inc.). The first centrifugation is performed at 3200 rpm for 9 minutes, followed by a second centrifugation at 1500 rpm for 5 minutes, resulting in approximately 2 mL of PRP. A single injection of 2 mL PRP is administered under sterile conditions and ultrasound guidance into the CMC-I joint, consisting of 1 mL intra-articular and 1 mL peri-articular injection. No repeated injections are performed.

  • Saline (0.9% NaCl)

    Drug

    Participants receive a placebo injection consisting of 2 mL sterile saline (0.9% NaCl), administered under sterile conditions and ultrasound guidance into the CMC-I joint. The injection protocol is identical to the PRP group, with 1 mL injected intra-articularly and 1 mL peri-articularly. To maintain blinding, participants in the placebo group undergo a venous blood draw mimicking the PRP preparation procedure; however, the collected blood is discarded. The duration and procedural steps are standardized to ensure comparable treatment conditions between groups. No repeated injections are performed.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Platelet-rich plasma group AExperimental treatment 1 intervention
Group B: Placebo group BPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical pain improvement: Visual Analog Scale (VAS) for pain

Pain will be assessed using the Visual Analog Scale (VAS), a continuous scale ranging from 0 to 100, where 0 indicates no pain and 100 indicates worst imaginable pain. A decrease in VAS score reflects an improvement in pain.

Time frame
3, 6, 9 and 12 months

Secondary outcomes

1

Functional improvement: Michigan Hand Outcomes Questionnaire (MHQ-DLV)

Hand function will be assessed using the Michigan Hand Outcomes Questionnaire (MHQ), Dutch Language Version (MHQ-DLV). The MHQ is a patient-reported outcome measure consisting of multiple domains (including overall hand function, activities of daily living, pain, work performance, aesthetics, and patient satisfaction), each scored on a scale from 0 to 100. For all domains except pain, higher scores indicate better hand function and greater satisfaction. For the pain domain, higher scores indicate more severe pain.

Time frame
3, 6, 9 and 12 months
2

Functional improvement: Grip and pinch test

Time frame
3, 6, 9 and 12 months
3

Functional improvement: Opposition of the thumb (pollexograph)

Time frame
3, 6, 9 and 12 months
4

Functional improvement: Kapandji Opposition Score

Thumb opposition will be assessed using the Kapandji Opposition Score, a clinical scale ranging from 0 to 10, where 0 indicates no opposition and 10 indicates maximal opposition of the thumb across the palm. Higher scores indicate better thumb function and greater range of opposition.

Time frame
3, 6, 9 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Goed Medisch Centrum

Lead sponsor

Arthrex, Inc.

Collaborator

Source ClinicalTrials.gov
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